Phase 2
N=76
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Autoantibody Positive · Non-diabetic Relatives at Risk for Type 1 Diabetes · High Risk · Impaired Glucose Tolerance
Bottom Line
View on ClinicalTrials.gov: NCT01030861 ↗Enrolled (actual)
76
Serious AEs
11.8%
Results posted
Aug 2020
Primary outcome: Primary: Rate of New Diabetes Per Year — 43; 72 N diabetes per 100 participant years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Teplizumab (Drug); Placebo infusion (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of New Diabetes Per Year |
43; 72 | — |
| SECONDARY Number of Participants With Adverse Events |
43; 23 | — |
Summary
The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
Eligibility Criteria
Inclusion Criteria
- Between ages of 8-45 years
- Have a relative with type 1 diabetes
- If first degree relative must be 8-45 years old (brother, sister, parent, offspring)
- If second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle, grandchild, cousin)
- Abnormal glucose tolerance by OGTT confirmed with 7 weeks of baseline visit [fasting blood glucose greater than 110mg/dL or and less than 126 mg/dL OR 2 hour glucose greater or equal to 140 mg/dL and less than 200 mg/dL OR 30, 60, or 90 minute value on OGTT greater than or equal to 200 mg/dL]
- Presence of at least two confirmed diabetes autoantibodies
Exclusion Criteria
- type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater or equal to 126 mg/dL or 2 hour glucose greater or equal to 200 mg/dL]
- abnormalities in blood counts, liver enzymes, international normalised ratio (INR),
- positive purified protein derivative (PPD) test
- vaccination with live virus within 6 weeks of randomization
- evidence of acute infection based on laboratory testing or clinical evidence
- serological evidence of past current or past HIV , hepatitis B, or hepatitis C infection
- Be currently pregnant or lactating
- Prior treatment with study drug
- Prior treatment with other monoclonal antibody in past one year
Data sourced from ClinicalTrials.gov (NCT01030861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.